Biopsy tool and method

ABSTRACT

A biopsy sample forming and extraction tool is described. The tool has a hollow handle, within which is enclosed a hollow cylindrical cutting tube. By manipulating a toolhead, the tube can be withdrawn from the handle and mounted on the handle in a tube exposed operating position. The tube is then inserted into a tissue body. if the tissue body is relatively thin, the tube completely penetrates the body and defines a biopsy sample core which is retained within the tube. The tube is then withdrawn from the tissue body, the toolhead is detached from the handle, the head and tube are reversed in positions relative to the handle, and the tube is again reinserted into the handle in a tube enclosed carrying position. The tool can then be conveniently sent to a remote laboratory where the tool and tube are opened and the sample is extracted for examination. If the tissue body is relatively thick and the constituent tissue strong, tube insertion does not completely sever the sample core. Under these circumstances, the tube is withdrawn from the tissue body, and a longitudinal tube half is broken away along a line of separation and a frangible hinge. One tube half is then reinserted into the tissue cut to sever and extract the biopsy sample core.

United States Patent 1 Lacey [4 1 Oct. 21, 1975 BIOPSY TOOL AND METHOD [75] Inventor: Robert L. Lacey, Palatine, Ill.

[73] Assignee: Illinois Tool Works Inc., Chicago,

[22] Filed: July 17, 1974 [21'] Appl. No.: 489,451

[52] US. Cl 128/2 B; 30/113.l; 30/122; 128/310; 128/347 [51] Int. Cl. A61B 10/00 [58] Field of Search 128/2 W, 2 B, 310, 329, 128/347; 30/122, 113.1, 278

[56] References Cited UNITED STATES PATENTS 2,198,319 4/1940 Silverman 128/2 B 2,835,246 5/1958 Boettger 128/2 W 2,919,692 1/1960 Ackermann 128/2 B 3,007,471 11/1961 McClure, Jr. 128/2 B 3,577,979 5/1971 VanderGaastt 128/2 B 3,596,658 8/1971 Lange et al. 128/2l4.4

3,653,388 4/1972 Tenckhoff 128/347 3,838,681 10/1974 Dalton 128/2 B Primary ExaminerKyle L. Howell Attorney, Agent, or Firm-Olson, Trexler, Wolters, Bushnell & Fosse, Ltd.

[57] ABSTRACT A biopsy sample forming and extraction tool is described. The tool has a-hollow handle, within which is enclosed a hollow cylindrical cutting tube. By manipulating a toolhead, the tube can be withdrawn from the handle and mounted on the handle in a tube exposed operating position. The tube is then inserted into a tissue body. if the tissue body is relatively thin, the tube completely penetrates the body and defines a biopsy sample core which is retained within the tube, The tube is then withdrawn from the tissue body, the toolhead is detached from the handle, the head and tube are reversed in positions relative to the handle, and the tube is again reinserted into the handle in a tube enclosed carrying position. The tool can then be conveniently sent to a remote laboratory where the tool and tube are opened and the sample is extracted for examination. 1f the tissue body is relatively thick and the constituent tissue strong, tube insertion does not completely sever the sample core. Under these circumstances, the tube is withdrawn from the tissue body, and a longitudinal tube half is broken away along a line of separation and a frangible hinge. One tube half is then reinserted into the tissue cut to sever and extract the biopsy sample core.

11 Claims, '12 Drawing Figures US. Patent Oct. 21, 1975 SheetlofZ 3,913,566

zffflfllfrllll ilu! U.S. Patent Oct. 21, 1975 Sheet 2 ofi 3,913,566

BIOPSY TOOL AND METHOD BACKGROUND OF THE INVENTION This invention relates generally to devices which can be inserted into a human or other penetrable-tissue body, and more particularly concerns a tool for obtaining biopsy samples.

Recently, techniques and equipment for inserting catheter tubes and like objects into tissue masses such as the human body have been greatly improved. Among the devices adapted to assist in catheter insertion are those disclosed in US. Pat. Nos. 3,359,978, 3,584,625, 3,596,658, and 3,61 1,695.

Until now, however, the extraction of sample tissue from a tissue mass for biopsy analysis has been difficult, and sometimes messy and painful to a human patient. With some sample tissue removal techniques and equipment, damage to surrounding tissue has been relatively great. Damage to the tissue sample itself can make the subject analysis difficult or unenlightening for the analyst.

It is accordingly the general object of the present invention to provide a device for neatly removing a small biopsy tissue sample from a human body or other tissue mass.

It is another object of the invention to provide such a device which does not excessively damage either the biopsy core sample or surrounding tissue. A related object is to provide a device for taking such a biopsy sample which cleanly cuts the body tissue over a minimal area, and which discourages tearing or otherwise damaging either the core sample itself or adjacent tissue.

Another object is to provide a sample extracting tool which can be used to form, sever and extract a sample of relatively great depth.

Still another object is to provide a sample extracting tool which can be used to neatly form, sever, extract and carry a sample from even a thin tissue body.

A further object of the invention is to provide such a device at a low manufactured cost.

Still another object is to provide such a device which can be used by even inexperienced personnel. A related object is to provide a tool which does not require great dexterity for proper use.

Yet another object of the invention is to provide a sample extraction tool which can be kept clean prior to use with relative ease. A related object is to provide a sampletaking tool which is used but a single time, and which can be thereafter discarded, thereby obviating subsequent sterilization requirements.

Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings. Throughout the description, like reference numerals refer to like parts.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the novel biopsy sample tool as it appears when being extracted from a sterile package;

FIG. 2 is a perspective view similar to FIG. 1 showing the novel biopsy sample tool as it appears when the tube member is being extracted from the handle member;

FIG. 3 is a perspective view of the novel biopsy sample too] similar to FIGS. 1 and2 as the tool appears when the tool tube is attached to the handle in a tube exposed operating position, a tube cover member being withdrawn from the tube;

FIG. 4 is an elevational side view of a tool as it appears when it is being inserted into a tissue body;

FIG. 5 is a fragmentary elevational view of the tool sample tube as it appears when it is inserted into a thin tissue body, portions of the tube and tissue body being broken away for illustrative purposes;

FIG. 6 is a fragmentary elevational view similar to FIG. 5 but showing the tube as it appears when inserted into the thick tissue body;

FIG. 7 is a fragmentary elevational view of the thick tissue body of FIG. 6 as it appears after the sample tube has been temporarily withdrawn;

FIG. 8 is a perspective view of the tool and sample tube as they appear when the sample tube is being prepared for reinsertion into the tissue sample of FIG. 7;

FIG. 9 is a side elevational view similar to FIG. 6 showing the tube as it appears when reinserted into the sample body;

FIG. 10 is a sectional view taken substantially in the plane of line 10-10 in FIG. 9 and showing in further detail the tool sample tube as it appears prior to breakaway;

FIG. 11 is a fragmentary side elevational view similar to FIG. 5 showing the broken-away sample tube reinserted into the tissue sample body; and

FIG. 12 is a side elevational view similar to FIG. 11 showing the sample body, the tube and the sample core as they appear when the sample core is being extracted from the sample tissue body.

DETAILED DESCRIPTION While the invention will be described in connection with a preferred embodiment and procedure, it will be understood that it is not intended to limit the invention to this embodiment or procedure. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention.

Turning first to FIGS. 1-3, there is shown a novel tool 20 for obtaining biopsy samples and the like. To promote maintenance of a sterile tool condition, the tool 20 can be enclosed in a sterile shipping bag 21, which can be opened and the tool extracted for use. Broadly speaking, the tool 20 can be considered to include a hollow handle 22 of generally cylindrical configuration, and a hollow, axially elongated cylindrical tube member 23 which can be interconnected to the handle 22 in either of two positions by a head 24. The tube is then reversed, as shown sequentially in FIGS. 1-3, and is reattached to the handle 20 in a tube exposed operating position such as that illustrated in FIG. 3. In accordance with one aspect of the invention, the handle is adapted to receive the tube member and securely engage the head to encase the tube member and any sample within the handle, as can be envisioned from FIGS. 1 and 2; alternatively, the handle can securely mount the tube in an exposed operating position as shown in FIG. 3. To accomplish this, the handle 22 and head 24 are provided with bi-positionally matable land, groove and thread surfaces 25-28 inclusive, to permit the head 24 to be mounted on the handle 22 in either of the two described positions. In the illustrated embodiment, this tracted from its storage position within the handle 20. It will be observed that the handle can be conveniently provided with fluting 30, knurling or other conveniently formed aggressive surface finish to encourage deft tool use. In addition, an expanded handle end 31 is provided to assist in too] manipulation under even slippery conditions.

In accordance with another aspect of the invention,

21, and the fingertab 29 is rotated relative to the handle 22 to permit extraction of the tube 23 from the carrying position, as illustrated in FIG. 2. The tube 23 and head 24 are then reversed and mounted on the handle 22, as shown in FIG. 3. In the illustrated embodiment, a sterile sleeve 36 (mounted on the tube 23 to further assure tube cleanliness) is then removed from the tube. The tool is then addressed for insertion into a tissue body 40 from which it is desired to take a sample core, as shown in FIG. .4.

It will be noted that the distal end 33 of the tube is formed to include a right conically bevelled cutting edge 37 in a plane perpendicular to the tube axis A. This cutting edge 37 has no relatively sharp points to catch on or become misdirected in the tissue during tool manipulation. With the edge 37 so formed tissue tearing and damage is minimized. In the illustrated embodiment, this cutting edge 37 forms a cylindrical cut 38 which either partially or completely defines a biopsy sample core with a minimum of damage to the surrounding tissue.

It is contemplated that tissue sample cores can be taken from either a relatively thin tissue body 40 such as that shown in FIG. 5, or a thicker tissue body 41 such as that shown in FIGS. 6, 7, 9, l1 and 12. When the tissue body 40 is relatively thin, as shown in FIG. 5,the sample core 42 is cut and is completely defined by simple insertion of the tool completely through the tissue body. When the tool 20 is pulled away from the tissue body 40 and the tube 23 is extracted, the tube-enclosed sample core 42 is also simultaneously extracted.

When the sample core 42 is found to be entirely retained within the hollow tube 23, the tube can be disconnected from its tube exposed operating position, reversed in its orientation, and reinserted into the handle 22, as illustrated in FIG.'2. The tube and contained sample are thus securely preserved for transportation to a laboratory or other location where sample analysis is to be conducted.

It is a feature of the invention that the tool can be used to quickly and deftly remove samples 43 such as those shown in FIGS. 6, 7, 9, 11 and 12 from relatively thick tissue bodies 41 or from locations where, for some reason, the sample core 43 is not completely severed from the surrounding tissue body. Under these circumstances, the tube is first inserted to form the cylindrical cut 38 which partially defines the sample core 43, as illustrated sequentially in FIGS. 6 and 7. The tool is then extracted from the tissue body and is quickly and easily modified for further extractive steps.

It is another feature of the invention that a neat and relatively painless incision can be made into the tissue body 41 by the tool 20 as it is inserted. To this end, the tube 23 is preferably rotated about its ownaxis A by appropriate manipulation of the tool handle 22. To encourage and make easy such rotating tube motion, the cylindrical handle 22 and head 24 are designed to colocate the longitudinal axis of the tube handle 22 with the tube axis A.

This tool modification is shown particularly in FIGS. 8-l1. At its proximal end 34, the tube 23 terminates in two wings 47 and 48 which are integrally formed with thetube on generally opposite sides. In carrying out the invention, the novel sample core cutting and forming tool can be rapidly and easily transformed into a sample core extraction tool by simply grasping and rotatively moving or bending one wing 47 away from the opposite'wing 48, as illustrated particularly in FIG. 8.

To assist in transforming the tool 20 into a biopsy core sample extraction tool, the tube 23 is formed during manufacture with a slit or line of separation 50, defined by two abutting tube lips 51 and 52 (see FIG. 10) along one tube side. This line of separation here extends'longitudinally' along the length of the tube, and is oriented in a direction parallel to the tube axis A. Elsewhere on the tube, as at a diametrically opposed location, a frangible hinge 54 is formed. This frangible hinge 54 includes longitudinally extended scores 56 extending substantially through the entire thickness of the tube 23. Between the scores 56, frangible connecting webs 57 are formed integrally with the tube. When separation of the tube'23 into tube halves 58 and 59 is desired, the connecting webs 57 are fractured as the needle is opened along the line of separation by relative rotation of the wing members 47 and 48. It will be understood that other convenient frangible hinge constructions of known type could be used.

When the two tube halves 58 and 59 are broken away from one another, smooth, linear tube portion edges 60-63, inclusive, are formed, as shown in FIG. 8. These smooth edges and the relatively unpointed cutting edges 37 permit reinsertion of the tool into the tissue body 41' along the previously formed cylindrical cut 38 with minimal damage to the adjacent tissue, as shown in FIG. 11.

I It will be understood that in the illustrated embodiment' only one wing48 and: the immediately adjacent tube part 59 is imbedded in or is affixed to the head 24. The remaining wing 47 and associated tube half 58 is not affixedly connected to the head 24, but remains, rather, joined thereto only by the frangible hinge 54. If it is desired to enhance the ease with which the nonimbedded or free wing 47 can be grasped for break away action,the wing 47 can be formed with a top 64 extending above adjacent handle surfaces.

To completely remove the tissue sample 43 from a relatively thick body 41', a tube .half 58 is broken away, as explained above, thus preparing the remaining tube half 59 for reinsertion into the tissue body 41 along the cut 38; It is to be noted that, as this point, the sample 43 is still joined to the surrounding tissue body 44 through the unbroken bottom region 65 of the core 43. The handle-"connected tube half 59 is then reinserted along the previously made cut 42 by rotative, insertional toolrnotion. Preferably, the tool is inserted along the cut 38 to a depth less than the full cut depth, as illustrated particularly in FIG. 11, and is then tilted away from the cut sample core 43 to a position similar to that illustrated in FIG. 12. The tilted extraction tool is then forced further into the tissue body 41 an incremental distance sufficient to sever the sample core 43 from the bottom tissue 65. The sample core extraction tool and the now-severed sample 43 are then extracted simultaneously from the tissue body 41, as illustrated in FIG. 12. If desired, and if necessary, the previously brokenaway tube half 58 can be used to assist in this manipulation and extraction process. If desired, the sample 43 and the tube half 59 can be disconnected from the hollow handle 22 and reinserted thereinto for transportation to the laboratory or other examination location.

The invention is claimed as follows:

1. An initially one-piece device for obtaining biopsy samples and the like, including a hollow, axially elongated cylindrical tube member having a distal end and a proximal end, the distal end including a right conically bevelled cutting edge in a plane perpendicular to the tube axis which is adapted to cut and partially form a cylindrical biopsy sample core in a body, the tube member having both a line of separation and an oppositely disposed frangible hinge means extending longitudinally along the length of the tube in opposed relation to permit division to the tube into two separate halves defined by at least one substantially smooth linear edge, a wing member attached generally at the proximal end to each tube half and adapted to facilitate rotation and separation of the tube halves, at least one separated tube half and attached wing member so formed being adapted for use as a biopsy sample extraction tool for severing and extracting the biopsy sample core from the body which was cut by both halves before their separation, head means attached to one wing member to permit easy manipulation of the integral wing and tube half as the sample extraction tool, at least a portion of the other wing member being spaced apart from said head to permit said other wing member to be easily grasped and rolled relative to the head and head-grasped wing to frangibly fracture said hinge means.

2. A device according to claim 1 including a hollow handle having at least one open end enclosingly receiving the tube member and securely engaging the head to encase the tube member and any sample within the hollow handle.

3. A device according to claim 2 wherein said handle and said head are each provided with cooperative means to permit the head to be mounted on the handle in a tube exposed operating position and alternatively in a tube enclosed carrying position.

4. A device according to claim 3 wherein said handle includes a cylindrical grasping portion and wherein said tube is mounted on said handle in a position having the tube axis congruent with the handle cylindrical grasping portion axis.

5. A method of extracting a biopsy sample from a body by using a tool having a frangible hollow tube and a distal end cutting edge, including the steps of inserting the tube cutting edge first into the body to cut and at least partially define a biopsy sample core, extracting the tool from the body, breaking away at least part of the tube to form a sample extraction tool, reinserting the extraction tool into the body along the previously made cut, severing the sample core from the body, and extracting the sample core and extracting tool from the body.

6. A method according to claim 5 wherein a cylindrical cut of predetermined depth is made by inserting the tube into the body, and including the steps of reinserting the extraction tool into the body along the previously made cut to a depth less than the full cut depth to permit severance and extraction of the sample core with minimal damage to body tissue.

7. A method according to claim 5 including the steps of tilting the reinserted extraction tool away from the cut sample core, and thereafter forcing the tilted extraction tool into the body an incremental distance sufficient to sever the sample core from the body.

8. A method according to claim 5 including the step of manipulating the broken-away tube part to assist in removing the sample core from the body.

9. A method according to claim 5 including the steps of simultaneously extracting the sample core and the tool from the body, the sample core bing carried in the sample extraction tool.

10. A method according to claim 5 including the step of rotatably bending one portion of the tool tube away from another portion along a frangible hinge to cause tube breakage and extraction tool formation.

11. A method of extracting a biopsy sample from a body by using a tool having a frangible hollow tube, a head affixed to at least part of the tube, and a hollow handle member into which the tube fits and the head cooperates at the open end of said handle, including the steps of extracting the tube from the handle, inverting the tube and reconnecting the head to the handle to locate the tube in a tube exposed operating position, inserting the tube into the body to cut and define a biopsy sample core, extracting the tube from the body, breaking away at least part of the tube to form a sample extraction tool, reinserting the extraction tool into the body along the previously made cut, severing the sample core from the body, extracting the sample core and tool from the body, disconnecting said head and handle, reinverting said tube and reconnecting the head to the handle to locate the tube and the sample core inside the handle in a tube enclosed carrying position. 

1. An initially one-piece device for obtaining biopsy samples and the like, including a hollow, axially elongated cylindrical tube member having a distal end and a proximal end, the distal end including a right conically bevelled cutting edge in a plane perpendicular to the tube axis which is adapted to cut and partially form a cylindrical biopsy sample core in a body, the tube member having both a line of separation and an oppositely disposed frangible hinge means extending longitudinally along the length of the tube in opposed relation to permit division to the tube into two separate halves defined by at least one substantially smooth linear edge, a wing member attached generally at the proximal end to each tube half and adapted to facilitate rotation and separation of the tube halves, at least one separated tube half and attached wing member so formed being adapted for use as a biopsy sample extraction tool for severing and extracting the biopsy sample core from the body which was cut by both halves before their separation, head means attached to one wing member to permit easy manipulation of the integral wing and tube half as the sample extraction tool, at least a portion of the other wing member being spaced apart from said head to permit said other wing member to be easily grasped and rolled relative to the head and head-grasped wing to frangibly fracture said hinge means.
 2. A device according to claim 1 including a hollow handle having at least one open end enclosingly receiving the tube member and securely engaging the head to encase the tube member and any sample within the hollow handle.
 3. A device according to claim 2 wherein said handle and said head are each provided with cooperative means to permit the head to be mounted on the handle in a tube exposed operating position and alternatively in a tube enclosed carrying position.
 4. A device according to claim 3 wherein said handle includes a cylindrical grasping portion and wherein said tube is mounted on said handle in a position having the tube axis congruent with the handle cylindrical grasping portion axis.
 5. A method of extracting a biopsy sample from a body by using a tool having a frangible hollow tube and a distal end cutting edge, including the steps of inserting the tube cutting edge first into the body to cut and at least partially define a biopsy sample core, extracting the tool from the body, breaking away at least part of the tube to form a sample extraction tool, reinserting the extraction tool into the body along the previously made cut, severing the sample core from the body, and extracting the sample core and extracting tool from the body.
 6. A method according to claim 5 wherein a cylindrical cut of predetermined depth is made by inserting the tube into the body, and including the steps of reinserting the extraction tool into the body along the previously made cut to a depth less than the full cut depth to permit severance and extraction of the sample core with minimal damage to body tissue.
 7. A method according to claim 5 including the steps of tilting the reinserted extraction tool away from the cut sample core, and thereafter forcing the tilted extraction tool into the body an incremental distance sufficient to sever the sample core from the body.
 8. A method according to claim 5 including the step of manipulating the broken-away tube part to assist in removing the sample core from the body.
 9. A method according to claim 5 including the steps of simultaneously extracting the sample core and the tool from the body, the sample core bing carried in the sample extraction Tool.
 10. A method according to claim 5 including the step of rotatably bending one portion of the tool tube away from another portion along a frangible hinge to cause tube breakage and extraction tool formation.
 11. A method of extracting a biopsy sample from a body by using a tool having a frangible hollow tube, a head affixed to at least part of the tube, and a hollow handle member into which the tube fits and the head cooperates at the open end of said handle, including the steps of extracting the tube from the handle, inverting the tube and reconnecting the head to the handle to locate the tube in a tube exposed operating position, inserting the tube into the body to cut and define a biopsy sample core, extracting the tube from the body, breaking away at least part of the tube to form a sample extraction tool, reinserting the extraction tool into the body along the previously made cut, severing the sample core from the body, extracting the sample core and tool from the body, disconnecting said head and handle, reinverting said tube and reconnecting the head to the handle to locate the tube and the sample core inside the handle in a tube enclosed carrying position. 